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Found 21420 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID: 671767 (history)  
Age: 0.33  
Gender: Female  
Location: California  
Vaccinated:2016-10-24
Onset:2016-10-27
   Days after vaccination:3
Submitted: 2016-11-22
   Days after onset:26
Entered: 2016-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / - RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M014926 / - LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M60991 / - RL / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Umbilical hernia
Diagnostic Lab Data: Referral given for specialty-Allergy/Immunology
CDC Split Type:

Write-up: Lumps at each site where vaccines were given.


VAERS ID: 668036 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2016-11-05
Onset:2016-11-05
   Days after vaccination:0
Submitted: 2016-11-22
   Days after onset:17
Entered: 2016-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 924357C / - LA / UN
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Diarrhoea, Fatigue, Hyperaemia, Injection site erythema, Injection site swelling, Mumps antibody test positive, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOSTER
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2016537181

Write-up: This is a spontaneous report from a contactable physician through a Pfizer sales representative. An about 54-year-old female patient of an unspecified ethnicity, received PREVENAR 13, (lot #924357C), via an unspecified route of administration, at single dose for immunization on the left arm on 05Nov2016. Concomitant medication included ZOSTER administered on 05Nov2016 in different arm. The patient''s medical history was not reported. In the same day she presented diarrhea, vomiting, prostration and weakness and went to hospital in the next day (06Nov2016) because also felt fever (it was not measured). She was hydrated and received medicine for pain. She informed that in this day, there was worsening of swelling and redness of left arm, where she received the vaccine (pneumococcal 13-val conj vac (dipht crm197 protein)). The patient informed physician that she had not been advised about the possible reactions that the vaccine could cause. On 11Nov2016 patient went again to hospital because she did not improve neither of reaction on site nor of prostration. She had no fever neither diarrhea on 11Nov2016. The physician examined the patient in the hospital. The patient was already using amoxicillin CLAVULIN on 11Nov2016. The physician of hospital wanted to hospitalize the patient, but it was not done. On 12Nov2016 the patient presented with cheek hyperemia. According to physician, it was requested serology for mumps and it showed IgG. The vaccination clinic was giving assistance to patient. The outcome of the events diarrhea, vomiting and pyrexia was reported as recovered, for the other adverse events was unknown. Sender''s Comments: A causal relationship between the administration of PREVENAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of concomitant medications an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 668039 (history)  
Age: 0.92  
Gender: Female  
Location: Foreign  
Vaccinated:2016-11-07
Onset:2016-11-09
   Days after vaccination:2
Submitted: 2016-11-23
   Days after onset:14
Entered: 2016-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER A71CB067A / - UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q01938 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Balance disorder, C-reactive protein increased, Clonus, Coordination abnormal, Hypotonia, Muscle tone disorder, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Tricuspid valve incompetence; Ventricular septal defect
Preexisting Conditions:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result: 17.4, Test Result Unit: mg/l; Test Name: WBC count; Result Unstructured Data: Test Result: decreased, unit: 2.8
CDC Split Type: DEPFIZER INC2016535187

Write-up: This is a spontaneous report from a contactable physician. This is a report received from regulatory authority. Regulatory authority report number DE-PEI-PEI2016089229. An 11-month-old female patient of an unspecified race received PREVENAR 13 (Lot # Q01938), at single dose and PRIORIX TETRA (Lot # A71CB067A), both intramuscular on 07Nov2016 for immunisation. Medical history included ongoing ventricular septal defect, ongoing tricuspid valve incompetence. The patient''s concomitant medications were not reported. On 09Nov2016, after vaccination the patient developed generalized coordination disturbance, balance disorder, clonic arm left and floppy arm right: muscle tone disorder, lasting for 1 day. The patient was hospitalized and condition was not life threatening. The patient underwent lab tests and procedures which included on an unspecified date included C-reactive protein: 17.4 mg/l and white blood cell count (WBC): decreased, unit: 2.8. The patient had recovered at the date of reporting. The patient was always conscious, the adverse events resolved spontaneously. Reporter''s causality assessement was possibly related to Priorix Tetra. No follow-up attempts needed, follow-up automatically provided by regulatory authority.


VAERS ID: 676368 (history)  
Age: 0.92  
Gender: Female  
Location: Foreign  
Vaccinated:2015-02-27
Onset:2016-04-19
   Days after vaccination:417
Submitted: 2016-11-23
   Days after onset:218
Entered: 2016-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / - RL / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abscess, Abscess rupture, Allergy to metals, Injection site abscess, Injection site granuloma, Injection site induration, Injection site infection, Injection site injury, Injection site nodule, Injection site pain, Injection site pruritus, Injection site scar, Injection site swelling, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Dtap-IPV-HIB vaccine, received on 24th June 2014, prophylaxis
Diagnostic Lab Data: On an unknown date Ultrasound scan was performed with result granuloma formation. 05/2016, Physical examination, scars on the thigh; Ultrasound scan, granuloma formation; 06/2016, Ultrasound scan, abscess in the thigh.
CDC Split Type: DK2016GSK168556

Write-up: This case was reported by a lawyer via local affiliate and described the occurrence of abscess rupture in a 2-year-old female patient who received INFANRIX. Co-suspect products included PREVENAR 13. Previously administered products included Dtap IPV (received on 24th June 2014). On 10th October 2014, the patient received INFANRIX. On 27th February 2015, the patient received PREVENAR 13. On 19th April 2015, 1 year and 192 days after receiving INFANRIX, the patient experienced abscess rupture (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site granuloma, injection site abscess, injection site nodule, injection site pain, injection site injury, injection site itching, injection site swelling, injection site infection, injection site scar and abdominal pain, injection site injury, injection site itching, injection site swelling, injection site infection, injection site scar and abdominal pain. The patient was treated with Chlorhexidine, FUCIDIN Cream, Antibiotics (Brand Unknown) and topical Antibiotic Ointment (Trade Name Unknown). On an unknown date, the outcome of the abscess rupture, injection site granuloma, injection site abscess, injection site nodule, injection site pain, injection site injury, injection site itching, injection site swelling, injection site infection, injection site scar and abdominal pain were unknown. The reporter considered the abscess rupture, injection site granuloma, injection site abscess, injection site nodule, injection site pain, injection site injury, injection site itching, injection site swelling, injection site infection and injection site scar to be related to INFANRIX. It was unknown if the reporter considered the abdominal pain to be related to INFANRIX. Additional details were provided as follows: All vaccines were given by the patient''s former practitioner and all three vaccines contained an aluminum adjuvant. Since the patient was healthy at the time of vaccination, and the vaccines were given as part of the childhood vaccination program to prevent possible diseases, it was also the patient Compensation''s assessment that the consequences after vaccination goes beyond what the patient should reasonably accept. The patient was therefore eligible for compensation and damages under the Act. The reporter had also sought damages because the reporter thinks after receiving vaccine the patient had suffered an injury in connection with the subsequent treatment of abscesses from doctors and at on call General Practitioner. After receiving vaccine hard knot was developed in the patient''s right thigh which subsequently developed into abscesses. The patient had got a damage following childhood vaccination program and experienced granulomas and abscesses in her thigh. The complications arose after 12 months vaccination. The patient had pain in the legs because of the abscesses. The reporter had posted photos showing the abscess and front of the patient''s thighs. On 15th February 2016, the patient was examined by doctors for abdominal pain, and at the same time densification of connective tissue in the right thigh. It was considered that it was a result of vaccination. There was no redness or signs of infection, and there was therefore no basis for further treatment, but they recommended that the patient should wait and see how it developed. Because of problems in the form of itching and swelling of the thigh. The complications developed in the same were where the vaccines were given and aluminum allergy, granulomas and itching was a well-known but were side effect of these vaccines. On 11th March 2016, the patient was examined again and the patient''s compensation estimated that the patient had not been harmed as a result of treatment by said doctors and had in their decision emphasized that in consultation with doctors, neither signs of infection or fever were present. The complications were rather described as vaccination reactions. There was still


VAERS ID: 676554 (history)  
Age: 0.25  
Gender: Female  
Location: Foreign  
Vaccinated:2015-05-07
Onset:2015-05-07
   Days after vaccination:0
Submitted: 2016-11-23
   Days after onset:566
Entered: 2016-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / - UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / - UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14C05A / - UN / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Angioedema, Asthenia, Blood pressure immeasurable, Cardiac failure, Generalised erythema, Oxygen saturation decreased, Pallor, Peripheral coldness, Peripheral swelling, Poor peripheral circulation, Pruritus generalised, Rash, Rash generalised, Urticaria
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 05/07/2015, Oxygen saturation, 92%
CDC Split Type: WAES1611JPN010135

Write-up: This is a spontaneous report from a contactable pediatrician. A 13 weeks old female patient of unspecified ethnicity received on 07May2015: PREVENAR 13, (lot number 14C05A, expiration date 28Feb2017) subcutaneously at 0.5 ml single, QUATTROVAC subcutaneously, at 1 DF single, BIMMUGEN subcutaneously, at 1 DF single, ACT-HIB subcutaneously, at 1 DF singe and ROTATEQ orally, at 1 DF single. Medical history and concomitant medications were unknown. The patient had no particular allergy history. On 07May2015, the patient (outpatient) experienced anaphylactic shock (grade 2) after simultaneous vaccinations. Five minutes after vaccination, the patient had rash on her soles, and subsequently she also presented marked lower thigh swelling, pale face, and loss of energy. The rash extended to the face. Oxygen monitoring revealed a SpO2 of 92% in room air; therefore, oxygen administration was started. The patient was transferred to the reporter''s hospital by ambulance. One hour later, she arrived at the hospital. At the time of consultation, the patient cried so much with a favorable complexion. Generalized urticaria was the only symptom noted at that time. The patient received treatment with methylprednisolone and an unspecified antihistamine agent. After that, the urticaria was resolved. The reported accessory symptoms were generalized urticaria/erythema, angioedema, generalized pruritus with rash, decompensated cardiovascular shock, and decreased peripheral circulation. The event suddenly developed and rapidly progressed. The event resolved on an unspecified date. The reporter classified the event as non-serious and commented as follows: The event was considered as (grade 2) anaphylactic shock based on prolongation of rash, poor oxygenation, peripheral coldness and unmeasurable blood pressure, although there was also a possibility that the pale face noted immediately after vaccination was vasovagal reflex. Thereafter, the above-mentioned vaccines were then administered separately to the patient, and mild rash was noted only after vaccination of BIMMUGEN, ACT-HIB, and PREVENAR 13. This suggested that there was a causal relationship between the symptom and these vaccines. The reporter considered that the patient might have developed an allergy to thimerosal, which was added to these vaccines at a very small amount. Follow-up (12Sep2016): New information from the same contactable pediatrician includes: patient age, gender, date of birth, additional co-suspect vaccines, vaccinations dates, posology, route of administration, lot numbers, expiry dates, event updated verbatim, onset date, stop date, outcome, treatment received, event clinical course details, reporter seriousness and causality assessment. Follow-up attempts completed. No further information expected. The reporting physician considered anaphylactic shock (grade 2) as non-serious. Upon internal review, anaphylactic shock (grade 2) was considered to be serious due to other important medical event. The reporting physician felt that anaphylactic shock (grade 2) was related to rotavirus vaccine and considered pneumococcal 13-val conj vac (dipht CRM 197 protein), diphtheria vaccine/pertussis vaccine/polio vaccine/tetanus vaccine, hepatitis B vaccine and haemophilus influenza type B vaccine as other suspect drugs. No further information is available.


VAERS ID: 676556 (history)  
Age: 0.2  
Gender: Unknown  
Location: Foreign  
Vaccinated:2016-11-10
Onset:0000-00-00
Submitted: 2016-11-23
Entered: 2016-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / 0 UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 0 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Eating disorder, Rotavirus test positive, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test (NOV-2016): positive. Aspartate aminotransferase (AST/SGOT) (NOV-2016): over 700 (units not provided). Alanine aminotransferase (ALT/SGPT) (NOV-2016): over 700 (units not provided). AST/SGOT (NOV-2016): dropped to 400 (units not provided). ALT/SGPT (NOV-2016): dropped to 400 (units not provided).
CDC Split Type: WAES1611KOR009612

Write-up: After receiving the 1st dose of ROTATEQ, the baby spouted out vomit and the baby vomited again after feeding. This spontaneous report was received from a physician and refers to a 2 month old patient of unknown gender. There was no information regarding the patient''s medical history or concurrent conditions provided. On 10-NOV-2016, the patient was vaccinated with the first dose of ROTATEQ (lot #, expiration date and dose were not reported; orally). Other suspect vaccines administered on the same day included first doses of PREVENAR 13, meningococcal vaccine (unspecified) (reported as meningitis vaccine) and TETRAXIM (lot numbers, expiration dates, site, doses and route of administration were not reported). After receiving the vaccines, on an unspecified date in November 2016, the baby spouted out vomit and vomited again after feeding. At the time of vomiting, the baby hardly ate and its body was sagged. Subsequently, on an unspecified date in November 2016, the patient was hospitalized due to the events and showed positive for rotavirus (it was not confirmed if the rotavirus was found via a stool analysis or another test). Therefore, the baby was isolated. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) tests performed on an unspecified date in November 2016 showed levels over 700 (units not provided). On the next day, AST/SGOT and ALT/SGPT levels dropped to 400 (units not provided). The outcome of AST/SGOT and ALT/SGPT levels over 700 (units not provided) was reported as recovering. The outcome of vomiting, eating disorder, sagged body and positive test for rotavirus was unknown. The relatedness between the events and ROTATEQ was not reported. The physician considered all reported events to be serious due to hospitalization. Additional information is not expected as follow-up is not possible.


VAERS ID: 667513 (history)  
Age: 0.33  
Gender: Male  
Location: Kentucky  
Vaccinated:2016-11-08
Onset:2016-11-21
   Days after vaccination:13
Submitted: 2016-11-21
   Days after onset:0
Entered: 2016-11-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS M9L74 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M025193 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16562 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M019690 / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Death
SMQs:

Life Threatening? No
Died? Yes
   Date died: 2016-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fer-Iron
Current Illness: None
Preexisting Conditions: Reflux
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received report from family friend that patient passed away on 11-21-16, unknown cause of death.


VAERS ID: 667530 (history)  
Age: 78.0  
Gender: Female  
Location: Virginia  
Vaccinated:2016-11-16
Onset:2016-11-16
   Days after vaccination:0
Submitted: 2016-11-22
   Days after onset:6
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q02071 / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Erythema, Fatigue, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish Oil 300 mg-1,000 mg capsule cholecalciferol (vitamin D3) 1,000 unit capsule Zetia 10 mg tablet calcium carbonate 600 mg (1,500 mg) tablet fluticasone 50 mcg/actuation nasal spray,suspension Synthroid 137 mcg tablet Lopressor 50 mg tabl
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Associated symptoms include fatigue, weakness, Left arm redness, pain, itching. Treatment of Prednisone dose pack, Zyrtec for itching, referral to Ashtma and immunology return to clinic for worsening or unresolved symptoms.


VAERS ID: 667570 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-22
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / - UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2016534077

Write-up: This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date (2 years ago) at single dose for immunisation. The patient received also PNEUMOVAX 23 at the end of Sep2016 and influenza vaccine on unknown date. On unknown date the patient experienced that his arm was very sore.


VAERS ID: 667572 (history)  
Age: 87.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2016-11-09
Onset:0000-00-00
Submitted: 2016-11-22
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER A3AD2 / - LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97936 / - RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Zoster (Zostavax)~~0.00~Patient
Other Medications:
Current Illness: Allergy; Hard of hearing
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2016538324

Write-up: This is a spontaneous report from a contactable Pharmacist. An 87-years-old female patient received PREVNAR 13 Histamine related reactions, intramuscular in right deltoid on 09Nov2016 at 0.5 ml, single for immunisation , influenza vaccine (FLU SHOT) LOT #: A3AD2, Exp date: Sep2018, intramuscular in left arm on 09Nov2016 at 1 DF, single for an unspecified indication. Medical history included hypoacusis (the patient was extremely hard of hearing) and breast cancer from an unknown date and unknown if ongoing. The patient had histamine related reactions for ZOSTAVAX and had allergy to certain things but not to any latex or egg or protein derivatives. The patient''s concomitant medications were not reported. The patient experienced histamine reaction/allergic reaction (drug hypersensitivity) (non-serious) on an unspecified date in Nov2016 with outcome of not recovered. The reaction came up be a day or few hour after the vaccinations, she did not know exactly. However the exact start date of reaction not known by pharmacist. The patient was advised to get some Cortisol cream or to do some ice pack. The event did not require an emergency room or doctor visit.


VAERS ID: 667762 (history)  
Age: 66.0  
Gender: Female  
Location: Virginia  
Vaccinated:2016-11-17
Onset:2016-11-17
   Days after vaccination:0
Submitted: 2016-11-22
   Days after onset:5
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M035104 / 1 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Insomnia, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt developed pain/swelling along the length of arm to the fingertips over the course of a couple days. The pain was causing difficulty sleeping on affected arm, and it made it difficult for her to drive/lift her arm. She began taking Benadryl and Motrin which resolved the issue. She returned to the pharmacy on 11/21/16 to inform us of what happened and said that the pain/swelling has resolved.


VAERS ID: 667824 (history)  
Age: 74.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2016-11-15
Onset:2016-11-22
   Days after vaccination:7
Submitted: 2016-11-22
   Days after onset:0
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97936 / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Infection, Peripheral swelling, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: januvia, amlodipine, pravastatin, lantus, breo, losartan,
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient arm is swollen and warm to the touch. Dr said she has an infection.


VAERS ID: 667835 (history)  
Age: 64.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2016-11-15
Onset:2016-11-16
   Days after vaccination:1
Submitted: 2016-11-22
   Days after onset:6
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R19477 / 0 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Cellulitis, Decreased appetite, Erythema, Fatigue, Feeling cold
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had a PREVNAR vaccine on 11/15/16 in her left arm and flu shot in her right arm. She had chills, and fatigue for 2 days after the injections. She feels better today, she has less fatigue and chills. She had less of an appetite. This is little bit better today. Her left upper arm started with a small amount of redness the day after she received the PREVNAR vaccine, then the redness spread down her left arm to just above her elbow yesterday. Dx with cellulitis, ordered for cephalexin 500 mg po tid x 10 days.


VAERS ID: 667836 (history)  
Age: 65.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2016-11-15
Onset:2016-11-15
   Days after vaccination:0
Submitted: 2016-11-22
   Days after onset:7
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34936 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 2JX5Z / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling and Redness~Pneumo (Prevnar13)~1~65.08~Patient
Other Medications: unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient says her arms is red and swollen around the injection site.


VAERS ID: 667837 (history)  
Age: 67.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2016-11-15
Onset:2016-11-19
   Days after vaccination:4
Submitted: 2016-11-22
   Days after onset:3
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97935 / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Skin reaction, Skin warm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pantoprazole 40mg daily, fluoxetine 40mg daily, losartan-hctz 100mg-25mg daily, levothyroxine 100mcg daily, montelukast 10mg daily
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: There is redness that extends more than half the upper arm. She first noticed it on the 19th, but it has increased since then. There is a bruise, also, but it was noted on the consent from that a vein may have been punctured upon administration. There is no swelling/itching/pain to the area; however, it did seem warm to the touch. The patient also stated her arm was very sore and she could barely lift it for a couple days following administration. It is now 7 days post-vaccination and she can still feel slight soreness.


VAERS ID: 667846 (history)  
Age: 70.0  
Gender: Female  
Location: Washington  
Vaccinated:2016-10-21
Onset:2016-10-22
   Days after vaccination:1
Submitted: 2016-11-22
   Days after onset:31
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34936 / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: pt said felt it more than the flu
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Slight redness and swelling at injection site, pt saw nurse practioner and circled redness area pt came to pharmacy 4 days later swelling and redness gone still complained of pain. return to pharmacy 11-22-2016 and said still pain at injection site however not shoulder or elbow.


VAERS ID: 667850 (history)  
Age: 65.0  
Gender: Male  
Location: Unknown  
Vaccinated:2016-11-21
Onset:0000-00-00
Submitted: 2016-11-22
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI721AA / - - / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. MO39055 / - - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97936 / - - / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. MO35148 / - - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Headache
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills and headache.


VAERS ID: 667858 (history)  
Age: 0.5  
Gender: Male  
Location: Minnesota  
Vaccinated:2016-11-15
Onset:2016-11-15
   Days after vaccination:0
Submitted: 2016-11-22
   Days after onset:7
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / 2 LG / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 LG / IM

Administered by: Private       Purchased by: Private
Symptoms: Pyrexia, Rash erythematous, Rash macular, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: He is not taking anything.the only thing we tried to give was his food and formula (Alimentum).
Current Illness: No illness at time of vaccination
Preexisting Conditions: Failure to thrive, GERD, seizure like episodes
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bright red splotchy rash all over that showed up within the two hour span; fever spiked to 102 and has stayed about high 99s up to 100.7 as of 11/22/2016. Continued to monitor the fever. He hasnt ate much or drank much so we have pushed fluids and tiny amoints of pedialite. We gave one dose of tylenol however it didn''t help except take the edge off of fever to about 101 degree Fahrenheit. He has begun puking more since the vaccinations as well.


VAERS ID: 667861 (history)  
Age: 86.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2016-11-10
Onset:2016-11-14
   Days after vaccination:4
Submitted: 2016-11-22
   Days after onset:8
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16561 / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Injection site induration, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cozaar 50mg once daily
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient presented to pharmacy with following visual symptoms: redness, swelling, hardness at injection site. Patient says area was itchy.


VAERS ID: 667864 (history)  
Age: 71.0  
Gender: Male  
Location: Georgia  
Vaccinated:2016-10-19
Onset:2016-11-21
   Days after vaccination:33
Submitted: 2016-11-22
   Days after onset:1
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR 01664AA / - LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34935 / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. noted arm that had received vaccines approximately 1 month ago was still sore and he was unable to lift arm over head.


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